Medicenna Announces FDA Clearance of IND to Expand the Phase 1/2 ABILITY Study of MDNA11 to the United States
-- ABILITY Study is currently ongoing at clinical trial sites in
-- Preliminary update on safety, PK/PD, and biomarker data expected by year-end 2021
-- Initial efficacy data update expected in mid-2022
“Clearance of this IND application is an important accomplishment that adds to the positive momentum behind our MDNA11 program,” said Dr.
The ABILITY Study is designed to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of various doses of intravenously administered MDNA11 in patients with advanced, relapsed, or refractory solid tumors and includes an MDNA11 monotherapy arm, as well as a combination arm designed to evaluate MDNA11 with a checkpoint inhibitor. Approximately 80 patients are expected to be enrolled into the ABILITY Study. Following establishment of the recommended Phase 2 dose (RP2D) and treatment schedule in the study’s dose escalation phase, Medicenna plans to conduct a dose expansion phase that will enroll patients with renal cell carcinoma, melanoma, and other solid tumors in monotherapy and combination settings.
A preliminary update on safety, PK/PD, and biomarker data from early cohorts of patients enrolled in the dose escalation phase of the ABILITY Study this year is expected at the end of calendar 2021 with initial efficacy data update expected in mid-2022.
About the ABILITY Study
Medicenna’s Phase 1/2 ABILITY Study of MDNA11, the Company’s “beta-only” and long-acting IL-2 super-agonist, is designed to assess the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of various doses of intravenously administered MDNA11 in patients with advanced solid tumors. The study includes a monotherapy dose escalation phase followed by an expansion phase for both the MDNA11 monotherapy arm at the recommended phase 2 dose, and a combination arm designed to evaluate MDNA11 with a checkpoint inhibitor.
Medicenna is a clinical stage immunotherapy company focused on the development of novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first in class Empowered Superkines. Medicenna's long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior CD122 (IL-2 receptor beta) binding without CD25 (IL-2 receptor alpha) affinity thereby preferentially stimulating cancer killing effector T cells and NK cells. Medicenna’s early-stage BiSKITs™ program, (Bifunctional SuperKine ImmunoTherapies) is designed to enhance the ability of Superkines to treat immunologically “cold” tumors. Medicenna's IL-4 Empowered Superkine, MDNA55, has been studied in 5 clinical trials including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. MDNA55 has obtained Fast-Track and Orphan Drug status from the FDA and FDA/EMA, respectively.
This news release contains forward-looking statements within the meaning of applicable securities laws and relate to the future operations of the Company and other statements that are not historical facts including statements related to the clinical potential and development of MDNA11 and the anticipated timing for various results from studies related to MDNA11. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects", "believes", "seeks" and similar expressions. All statements other than statements of historical fact, included in this release, including but not limited to, the impact of the expansion of the ABILITY Study on the tumor types that may be explored with MDNA11, the rate of subject enrollment in the Company’s trial and the ABILITY Study and the timing of results from the Company’s trial and ABILITY Study, the anticipated timing and results of the Company’s trials and studies generally and the future plans and objectives of the Company, are forward-looking statements that are subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company's expectations include the risks detailed in the annual information form for the year ended
The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date hereof and except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements.
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Source: Medicenna Therapeutics Corp.